Sarepta volatility ‘name of the game’ into AdCom and PDUFA date, says Guggenheim

Guggenheim analyst Debjit Chattopadhyay notes that an article from STAT highlighted multiple interventions from the director of CBER to realign the review of Sarepta’s SRP-9001 with "his vision for cell and gene therapy approvals." Given that context, if the heads of CBER and OTP steer the upcoming advisory committee meeting, or AdCom, discussions towards the underlying scope and premise of the man-made micro-dystrophin, accelerated approval "could be the likely outcome." However, if the discussion is centered around external controls, the "outcome is far from certain." The firm, which says the "bottom-line" is that "volatility is the name of the game into" the May 12 AdCom meeting and May 29 PDUFA goal date for SRP-9001, has a Buy rating on Sarepta shares.